Looking for Regulatory Affairs jobs in India? Syneos Health is hiring a Regulatory Associate (EU Market, CMC Module 3) for its team. This full-time role is open in Gurugram (Hybrid) and Remote (Pre-approved) locations. Ideal for candidates with 6 months to 2 years of CMC experience in small molecules and exposure to EU, GCC, or APAC markets.
Contents
About the Company
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that helps customers accelerate drug development and commercialization. With deep expertise in clinical development, regulatory affairs, and commercialization, Syneos Health partners with innovators across the globe.
The company is known for its collaborative culture, strong focus on employee development, and commitment to diversity and inclusion. Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Job Details
- Company Name: Syneos Health
- Job Title: Regulatory Associate (EU Market, CMC Module 3)
- Requisition ID: 25105261
- Location: Gurugram (Hybrid) / Remote (Pre-approved)
- Job Type: Full-time
- Experience: 6 months – 2 years (Internship experience preferred)
- Posted: 2 days ago
Job Description
The Regulatory Associate will support the preparation and maintenance of regulatory submissions, with a focus on CMC (Chemistry, Manufacturing & Controls) Module 3 for the EU market. The role involves assisting with document preparation, quality checks, regulatory research, and lifecycle maintenance activities.
Essential Functions
- Assist in preparation of product development documents, gap analyses, and clinical development plans
- Support preparation of regulatory submissions including INDs, NDAs/MAAs, DMFs, variations, renewals, and Marketing Authorisation Transfers (MATs)
- Conduct regulatory research and support orphan drug designation requests
- Perform quality checks on regulatory documents
- Assist with submission of regulatory documents and general regulatory research
- Gather, compile, analyze, and report information
- Provide general support to clients and internal teams
Skills/Qualifications
- Minimum 6 months to 2 years of relevant experience in Regulatory Affairs
- Hands-on CMC experience in small molecules is mandatory
- Experience with EU market submissions is highly preferred (GCC / APAC exposure is a plus)
- Internship experience in regulatory affairs is preferred
- Excellent interpersonal and communication skills
- Advanced proficiency in Microsoft Office applications
- Strong analytical skills and high attention to detail
- Good time and project management skills
- Ability to work independently as well as in a team
- Fluent in English (speaking, writing, and reading)
Key Responsibilities
- Prepare and review CMC Module 3 documents for EU regulatory submissions
- Support lifecycle management activities including variations and renewals
- Conduct regulatory research and gap analysis
- Ensure quality and compliance of submission documents
- Track and maintain regulatory documentation
- Collaborate with cross-functional teams for timely submissions
Benefits/Perks
- Work in a global leader in biopharmaceutical solutions
- Opportunity for career growth and skill development in regulatory affairs
- Hybrid / Remote work options (pre-approved)
- Supportive and inclusive work culture
- Exposure to EU regulatory submissions and international markets
- Comprehensive learning and development programs
How to Apply
Apply directly for Requisition ID: 25105261 through the official Syneos Health Careers portal.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Syneos Career page.
🔗 Click below to apply directly for this job
For more Regulatory Affairs jobs, CMC jobs, pharma regulatory jobs in Gurugram, and opportunities across India, visit Pharma Recruiter.
Apply quickly if you have CMC experience in small molecules and EU market knowledge!
Why You Should Join Syneos Health
Syneos Health offers a dynamic environment where you can work on meaningful regulatory projects that impact drug development and patient access. With a strong focus on employee growth, inclusion, and innovation, the company provides excellent opportunities to build expertise in EU regulatory submissions while collaborating with talented professionals globally.
FAQs
What is the experience required for the Regulatory Associate role at Syneos Health?
Candidates need 6 months to 2 years of experience. Internship experience is preferred.
Is CMC experience mandatory?
Yes, hands-on CMC experience in small molecules is required.
Which markets are preferred for this role?
Experience with EU market is highly preferred. GCC and APAC exposure is an advantage.
Is the job fully remote?
The position is available as Remote (Pre-approved) or Gurugram Hybrid.
What documents will I work on?
You will primarily support CMC Module 3 for EU submissions, along with INDs, MAAs, variations, and other lifecycle documents.
